In patients with clinically significant third space fluid, consideration should be given to draining the effusion prior to ALIMTA administration.
Concomitant administration of nephrotoxic drugs or substances that are tubularly secreted could result in delayed clearance of ALIMTA.
Caution should be used when administering ibuprofen concurrently with ALIMTA to patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 mL/min). Patients with mild to moderate renal insufficiency should avoid taking NSAIDs with short elimination half-lives for a period of 2 days before, the day of, and 2 days following administration of ALIMTA. In the absence of data regarding potential interaction between ALIMTA and NSAIDs with longer half-lives, all patients taking these NSAIDs should interrupt dosing for at least 5 days before, the day of, and 2 days following ALIMTA administration. If concomitant administration of an NSAID is necessary, patients should be monitored closely for toxicity, especially myelosuppression, renal and gastrointestinal toxicities.
It is recommended that nursing be discontinued if the mother is being treated with ALIMTA.
ALIMTA should be administered under the supervision of a qualified physician experienced in the use of antineoplastic agents.
Dose adjustments may be necessary in patients with hepatic insufficiency.
Dosing and Modification Guidelines
Dose adjustments at the start of a subsequent cycle should be based on nadir hematologic counts or maximum nonhematologic toxicity from the preceding cycle of therapy. Modify or suspend therapy according to the Dosage Reduction Guidelines in the full Prescribing Information.
Abbreviated Adverse Events (% incidence)
The most common adverse events (grades 3/4) with ALIMTA versus docetaxel, respectively, for the treatment of patients with NSCLC were anemia (8 vs 7); leukopenia (5 vs 28); neutropenia (5 vs 40); thrombocytopenia (2 vs 1); ALT elevation (3 vs 1); febrile neutropenia (2 vs 13); infection without neutropenia (6 vs 4); infection/febrile neutropenia -- other (2 vs 1); fatigue (16 vs 17); thrombosis/embolism (3 vs 3); cardiac ischemia (3 vs 1); anorexia (5 vs 8); dyspnea (18 vs 26); and chest pain (7 vs 8). The most common clinically relevant adverse events (all grades) with ALIMTA versus docetaxel, respectively, were fatigue (87 vs 81); anorexia (62 vs 58); nausea (39 vs 25); constipation (30 vs 23); vomiting (25 vs 19); diarrhea (21 vs 34); stomatitis/pharyngitis (20 vs 23); edema (19 vs 24); dyspnea (72 vs 74); chest pain (38 vs 32); neuropathy/sensory (29 vs 32); infection without neutropenia (23 vs 17); anemia (33 vs 33); fever (26 vs 19); and rash (17 vs 9).
The most common adverse events (grades 3/4) with ALIMTA in combination with cisplatin versus cisplatin alone, respectively, for the treatment of patients with MPM were neutropenia (24 vs 4); leukopenia (16 vs 1); anemia (6 vs 0); thrombocytopenia (5 vs 0); infection without neutropenia (2 vs 0); infection with grade 3/4 neutropenia (1 vs 0); infection/febrile neutropenia -- other (1 vs 0); febrile neutropenia (1 vs 0); fatigue (17 vs 13); thrombosis/embolism (6 vs 4); nausea (12 vs 6); vomiting (11 vs 5); dyspnea (11 vs 7); and chest pain (9 vs 6). The most common clinically relevant adverse events (all grades) with ALIMTA in combination with cisplatin versus cisplatin alone, respectively, were neutropenia (58 vs 16); leukopenia (55 vs 20); anemia (33 vs 14); thrombocytopenia (27 vs 10); fatigue (80 vs 74); thrombosis/embolism (7 vs 4); nausea (84 vs 79); vomiting (58 vs 52); constipation (44 vs 39); anorexia (35 vs 25); stomatitis/pharyngitis (28 vs 9); diarrhea (26 vs 16); dyspnea (66 vs 62); chest pain (40 vs 30); and rash (22 vs 9).
See complete Warnings, Precautions, Adverse Reactions, and Dosage and Administration sections in the full Prescribing Information for safety and dosing guidelines.
(1) Scagliotti G, Purvish P, et al. Phase III study of pemetrexed plus cisplatin versus gemcitabine plus cisplatin in chemonaive patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Abstract PRS-3, 12th World Conference on Lung Cancer (WCLC) 2007. Journal of Thoracic Oncology, Vol 2 No 8, Supplement 4, Page S306, August 2007.
(2) American Cancer Society, "What Is Non-Small Cell Lung Cancer?," October 15, 2007, American Cancer Society, http://www.cancer.org/docroot/CRI/conten... ung_Cancer.asp?rnav=cri , (February 21, 2008).
(3) American Cancer Society, "How Is Non-Small Cell Lung Cancer Staged?" October 15, 2007, American Cancer Society, www.cancer.org/docroot/CRI/content/CRI_2_4_3x_How_Is_Non-Sma... er_Staged.asp?rnav=cri , (February 21, 2008).
(4) World Health Organization, Gender in Lung Cancer and Smoking Research, Department of Gender, Women and Health, 2003, http://www.who.int/gender/documents/en/l... .
(5) National Cancer Institute, "Non-Small Cell Lung Cancer Treatment (PDQ(R)) Health Professional Version," December 14, 2007, National Cancer Institute, www.cancer.gov/cancertopics/pdq/treatment/non-small-cell-lun... nal/page2 , (February 14, 2008).
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